The Efficacy of Pantoprazole Treatment in Patients With F... | NCT01608750

Studies
The Efficacy of Pantoprazole Treatment in Patients With Functional Dyspepsia

NCT01608750

Sponsor

Bezmialem Vakif University

Status

Unknown status

Last Update Posted

May 31, 2012Estimated

Enrollment

200Estimated

Phase

Phase 4

Conditions

Nonulcer Dyspepsia

Interventions

Pantoprazol
Folic Acid

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Dec 2012Estimated

Completion Date

Jun 2013Estimated

First Submitted Date

May 28, 2012

First Submission Date that Met QC Criteria

May 30, 2012

First Posted Date

May 31, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 30, 2012

Last Update Posted Date

May 31, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of our study is to evaluate the effectiveness of proton pump inhibitor (PPI) treatment in patients with functional dyspepsia.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
pantoprazole	Experimental		Drug: Pantoprazol
folic acid	Placebo Comparator		Drug: Folic Acid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pantoprazol	Drug	40mg/day, oral, 28 days	pantoprazole
Folic Acid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effectiveness of pantoprazole treatment in patients with functional dyspepsia measured by symptoms scale.		one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

aged 18-45 years with symptoms of dyspepsia,
no evidence of organic disease.

Exclusion Criteria:

Patients with alarm symptoms,
Severe concomitant illness,
Pregnancy or lactation,
Alcohol or drug abuse,
Use of aspirin or other non-steroidal anti-inflammatory drugs antibiotics, H2 receptor blockers, bismuth, or proton pump inhibitors in the preceding two weeks

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bezmialem medical faculty		Istanbul			Turkey (Türkiye)

Intervention Browse Module

MeSH Terms

ID	Term
D000077402	Pantoprazole
D005492	Folic Acid

Ancestor Terms

ID	Term
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D013457	Sulfur Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided